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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021127

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NDA 021127 describes OPTIVAR, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the OPTIVAR profile page.

The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for 021127

Tradename:	OPTIVAR
Applicant:	Mylan Speciality Lp
Ingredient:	azelastine hydrochloride
Patents:	0
Therapeutic Class:	Ophthalmic Agents Respiratory Tract Agents
Formulation / Manufacturing:	see details

Suppliers and Packaging for NDA: 021127

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127	NDA AUTHORIZED GENERIC	Wallace Pharmaceuticals Inc.	51525-7815	E	51525-7815-6

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	May 22, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021127

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	➤ Try a Free Trial	➤ Try a Free Trial
Mylan Speciality Lp	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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